Pharmacokinetics of cefonicid in lactating goats after intravenous, intramuscular and subcutaneous administration, and after a long-acting formulation for subcutaneous administration.

The single-dose disposition kinetics of cefonicid were determined in clinically normal lactating goats (n = 6) after intravenous (IV), intramuscular (IM) and subcutaneous (SC) administration of a conventional formulation, and after subcutaneous administration of a long-acting formulation (SC-LA). Cefonicid concentrations were determined by high performance liquid chromatography with ultraviolet detection. The concentration-time data were analysed by noncompartmental pharmacokinetic methods. Steady-state volume of distribution (Vss ) and clearance (Cl) of cefonicid after IV administration were 0.14 ± 0.03 L/kg and 0.51 ± 0.07 L/h·kg, respectively. Following IM, SC and SC-LA administration, cefonicid achieved maximum plasma concentrations of 14.46 ± 0.82, 11.98 ± 1.92 and 17.17 ± 2.45 mg/L at 0.26 ± 0.13, 0.42 ± 0.13 and 0.83 ± 0.20 hr, respectively. The absolute bioavailabilities after IM, SC and SC-LA routes were 75.34 ± 11.28%, 71.03 ± 19.14% and 102.84 ± 15.155%, respectively. After cefonicid analysis from milk samples, no concentrations were found above LOQ at any sampling time. From these data, cefonicid administered at 20 mg/kg each 12 hr after SC-LA could be effective to treat bacterial infections in lactating animals not affected by mastitis problems.

A successful treatment of necrotizing fasciitis following the surgery of distal radius plate removal: A case report and literature review.

RATIONALE: Necrotizing fasciitis (NF) is defined as a rare, rapidly progressive, and highly lethal skin infection characterized by necrosis of the fascia and subcutaneous tissue. PATIENT CONCERNS: The present study aims to discuss the case of a 35-year-old man who developed NF following a routine sterile right distal radius bone plate removal surgery. DIAGNOSES: The patient was suspected of NF based on his clinical manifestations, laboratory tests, and imaging results. The diagnosis of NF was confirmed by histological examinations. INTERVENTIONS: Serial prompt and extensive debridement was performed during the rapid and aggressive extension of the skin infection, together with antibiotics and supportive treatments. OUTCOMES: The condition of the patient finally improved on the sixth day of disease progression. Skin grafting of his right forearm wound was performed successfully 2 months after the admission. LESSONS: NF can occur during the perioperative period for routine clean radius plate removal operation in patients with no risk factor for NF. The objective is to remind the physicians to stay aware of this disease, especially its early clinical signs and symptoms. Urgent subsequent treatment, including surgical debridement, antibiotic therapy, and supporting management, is the key to ensure the survival and better prognosis of patients.

Empiric treatment with once-daily cefonicid and gentamicin for febrile non-neutropenic pediatric cancer patients with indwelling central venous catheters.

SUMMARY: The approach to treating febrile non-neutropenic hematooncologic patients with central venous catheters varies. We recently introduced once-daily administration of cefonicid and gentamicin for such children who were in good clinical condition and without focal signs of infection. Our 2-year experience of 125 episodes in 54 children is hereby reported. Absolute neutrophil counts were 550 to 16,700/mm. Bacteremia occurred in 6.4% episodes: only in patients with Hickman/Broviac catheters and not in those with port-a-caths [8/37 (21.6%) vs. 0/17 patients, P=0.046; 8/86 (9.3%) vs. 0/39 episodes, P=0.056]. The pathogens were coagulase-negative staphylococci (3), Streptococcus pneumoniae (2), Pseudomonas aeruginosa and Klebsiella pneumoniae (1), methicillin-sensitive Staphylococcus aureus (1), and Streptococcus milleri (1). All patients remained in stable clinical condition and all, except for 2 who became neutropenic and 1 with S. aureus bacteremia who developed cellulitis, defervesced while on the empiric therapy. Three episodes could not be managed as outpatients. No adverse effects were observed. We conclude that our approach is efficacious and safe and, furthermore, that empiric antibiotic therapy may not be indicated for selected patients with port-a-caths. Future study of children with Hickman/Broviac catheters will evaluate the use of cefonicid alone.

Prospective, randomized, double-blind study of prophylactic antibiotics in axillary lymph node dissection.

BACKGROUND: Antibiotic prophylaxis is controversial in patients undergoing axillary lymph node dissection (ALND). We determined whether preoperative antibiotics decreased incidence or treatment cost of infectious complications following ALND. METHODS: Two hundred patients entered this prospective, randomized, double-blind trial. Patients received either placebo or cefonicid preoperatively. Loco-regional signs of infection were monitored for 4 weeks postoperatively. RESULTS: There was a trend toward fewer infections in the prophylactic group (placebo 13% versus cefonicid 6%; P = 0.080). Cefonicid significantly decreased severe infections requiring hospitalization (placebo 8% versus cefonicid 1%; P = 0.033). Cefonicid also decreased the treatment cost of infection per patient ($49.80 versus $364.87). CONCLUSIONS: We demonstrated a trend toward fewer overall infections and significantly fewer severe infections in patients given prophylactic antibiotics, which translated into a decrease in the cost of treatment for infectious complications. These findings support antibiotic prophylaxis for patients undergoing ALND.

Treatment of staphylococcal septic arthritis in rabbits by systemic antibiotics and intra-articular corticosteroids.

OBJECTIVE: To assess the effect of intra-articular corticosteroids added to systemic antibiotics in experimental septic arthritis. METHODS: Rabbits were injected intra-articularly by Staphylococcus epidermidis. Rabbits received no additional treatment and served as control (group 1), were treated with systemic antibiotics (group 2), or treated with systemic antibiotics and intra-articular corticosteroids (group 3). After 15 days animals were killed and joint histopathological-histochemical parameters were assessed. RESULTS: All rabbits survived the experiment. The treated groups (2-3) had lower histological-histochemical scores in comparison with the untreated group (1). Group 3 had significantly lower scores in joint sections in comparison with group 2: (mean (SD) 6.5 (1.4) v 4.0 (1.0), p = 0.001 and 7.4 (2.6) v 4.2 (2.2), p = 0.01), because of lower damage expressed in clustering of chondrocytes, pannus formation, proteoglycan depletion, and synovitis. CONCLUSION: Addition of local corticosteroids to systemic antibiotics in septic arthritis seems to be harmless, and improves joint histological-histochemical parameters in this experimental setting.

The efficacy of a single dose antibiotic regimen in adults undergoing tonsillectomy.

Several studies have indicated that antibiotics given for 5-7 days post-tonsillectomy are beneficial. A prospective double blind randomized study was undertaken to evaluate the efficacy of a long-acting antibiotic (Cefonicid) given prophylactically at the time of tonsillectomy. Dependent variables were percent weight loss, number of doses of pain medications required postoperatively, the number of days required to resume a normal diet, and return to work. The results of all independent tests indicated that there were no statistically significant differences between the Cefonicid group and the placebo group. The results of this study indicate that single dose prophylactic application of Cefonicid is not effective in adults undergoing tonsillectomy.

Clindamycin/cefonicid in head and neck oncologic surgery: one-day prophylaxis is as effective as a three-day schedule.

The aim of our study was to evaluate the optimal duration of antibiotic prophylaxis in major oncologic surgery of the head and neck using a novel broad spectrum drug combination: clindamycin and cefonicid. A prospective randomized study was carried out on 126 evaluable patients undergoing clean-contaminated (skin to mucosa) surgery for cancer of larynx, pharynx or oral cavity. Cases at high surgical risk (because of need of pedicled or microvascular free flaps reconstruction), were excluded from the study. Within 20 days after surgery, only one case of wound infection was recorded among the 62 patients treated with the one-day schedule, versus three cases registered among the 64 subjects receiving three-day chemoprophylaxis. Episodes of systemic infections and eventual wound complications occurring in the first 20 days after surgery have also been recorded. The role of potential risk factors for postoperative complications has been evaluated. According to our findings, a three-day antibiotic regimen is not more effective than a short-term (one-day) schedule in preventing wound or systemic infection in clean-contaminated head and neck cancer surgery without flap reconstruction.

[Excretion of cefonicid and ceftriaxone into the saliva]. / Cefonicid és ceftriaxon nyálba történö kiválasztódásának vizsgálata.

The serum and saliva levels of cefonicid (Monocid) and ceftriaxon (Rocephin) were studied after iv. administration on mice. It was found that both of the antibiotics were secreted well into saliva and their therapeutic values remained for 4-5 hours.

Delayed allergic reaction to cefonicid.

We report a case of delayed cutaneous reaction to intramuscular treatment with cefonicid, a second generation cephalosporin. An isolated late skin test response was observed to cefonicid only and not to other beta-lactams. A patch test with cefonicid 1% was positive after 48 and 96 hours.

Disposition of intramuscular cefonicid in elderly patients.

OBJECTIVE: To examine the disposition of intramuscular (IM) cefonicid in elderly patients with bacterial pneumonia. DESIGN: Pharmacokinetic study. SETTING: A 620-bed university-affiliated long-term care institution with its own 39-bed acute care unit. PATIENTS: Nine consecutive elderly patients with bacterial pneumonia treated with IM cefonicid. MEASUREMENTS: Blood samples were collected on the seventh day of therapy over a 24-hour period and analyzed by high performance liquid chromatography. Pharmacokinetics parameters (volume of distribution, half-life, and clearance) and protein binding were calculated. Clinical outcome of IM cefonicid therapy was also noted. RESULTS: The estimated creatinine clearance (CIcr) ranged from 32 to 145 mL/min. Peak cefonicid serum concentrations occurred at 0.5-1.5 hours, with a mean value of 118 +/- 41 micrograms/mL. Cefonicid concentrations declined monoexponentially to 57 +/- 16 micrograms/mL at 12 hours and 28 +/- 14 micrograms/mL at 24 hours. The mean apparent distribution volume was 0.2 +/- 0.07 L/kg, and the mean apparent total clearance was 15 +/- 12 mL/min. The half-life ranged from 3.1 to 38 hours. A linear correlation was noted between Clcr and cefonicid clearance (r = 0.99). CONCLUSIONS: Cefonicid absorption was variable among these patients, and the serum half-life was longer than previous values noted in younger patients with similar degree of renal dysfunction. Pharmacokinetic and clinical outcome data from our study group indicate the potential role of IM cefonicid in treating elderly patients with bacterial pneumonia.

Prophylactic effect of the open vaginal vault method in reducing febrile morbidity in abdominal hysterectomy.

In a randomized study, we evaluated the efficacy of the "open vaginal vault" method of abdominal hysterectomy, when cefonicid is administrated preoperatively, in reducing postoperative febrile morbidity. The vaginal vault was left open in 72 patients and closed in 65 patients in control groups. No significant difference in postoperative febrile morbidity was noticed in the two groups.

Antimicrobial prophylaxis in urologic surgery: does it give some benefit?

Three types of antibiotic prophylactic regimens were evaluated versus a control without prophylaxis (group A: 3,912 cases) in urologic surgery. The antibiotic regimens were: group B = cefazolin 1 g/12 h/3 days (3,660 cases); group C = cefonicid 1 g/24 h/3 days (2,076 cases), and group D = cefonicid 1 g single dose (3,169 cases). The parameters used were the comparison of the corresponding rates of postsurgical sepsis and operative wound infections. Numeric investigations for the validity of a retrospective study (unpaired data) were performed: homogenicity test, relative risk point estimate and confidence limits (95%), and etiological fraction point estimate and confidence limits (95%). Chi-square for other purposes were performed. Endoscopic handling was considered homogeneous (same infective risk), while open surgery was heterogeneous (p < 0.001). In order to avoid probable bias, a correction factor was used. Although in different degrees, prophylaxis significantly reduced the morbidity of surgical wound infections (p < 0.001; etiological fraction > 90%). The differences (p < 0.01) between groups B and C/D were attributed to pharmacokinetic causes (short T 1/2 of cefazolin). To obtain the maximum protective effect, the use of antibiotics with a T 1/2 of > 4 h is suggested. There was no resistant mutans in previously sensitive strains. However, a significant selection of intrinsically resistant strains was observed. Monodose offers at lest the same advantages as multiple-dose therapy. In addition, the monodose selected in a lesser proportion both the resistant strains (p < 0.001) and the number of microbial associations (p < 0.01).

Comparison of single-dose antibiotic prophylaxis in uncomplicated transurethral resection of the prostate.

We evaluated the necessity for antibiotic prophylaxis in uncomplicated transurethral resection of the prostate. A total of 107 patients was entered into a double-blind, prospective, placebo-controlled, randomized trial. Only 7 patients were excluded because they had positive preoperative urine cultures. All patients received a single dose of either 1 gm. cefonicid or saline placebo intramuscularly before surgery. No further antibiotics were administered. Urine cultures were obtained intraoperatively, daily while hospitalized, and at 2 and 4 weeks postoperatively. A growth of 10(4) organisms constituted a positive urine culture. Postoperative infection rates were statistically significant with 12% (6 of 51) in the cefonicid group and 37% (18 of 49) in the placebo group (p = 0.003). During the initial 2 days postoperatively there were no infections in the cefonicid treated patients as opposed to 8 in the placebo group (p = 0.003). Our study demonstrated the need for antibiotic prophylaxis to prevent infection after uncomplicated transurethral resection of the prostate. This can be accomplished by using a single dose, broad-spectrum cephalosporin (cefonicid). This procedure simplifies the implementation and decreases the cost of prophylaxis for transurethral resection of the prostate.

[Prophylactic antibiotic therapy in extracorporeal shock-wave lithotripsy: prospective, randomized study]. / Antibioterapia profiláctica en la litotricia extracorpórea por ondas de choque (LEOC): estudio prospectivo y randomizado.

Two hundred patients that underwent ESWL were randomized into 4 groups in order to determine the benefits of antibiotic prophylaxis. All comparisons among groups were not statistically significant. Neither cephalosporin nor quinolone prophylaxis impacted significantly on bacteriuria rate after ESWL. Thus, in patients without infected stones, urinary tract obstruction and ancillary procedures ESWL could be performed without prophylactic antibiotic regimes.

Prophylaxis against infection. Single-dose cefonicid compared with multiple-dose cefamandole.

A total of 1489 patients were included in a prospective, randomized study that compared the efficacy of a single dose of cefonicid in 474 patients (Group I) with that of three doses of cefamandole in 510 patients (Group II) and five doses of cefamandole in 505 patients (Group III), for prophylaxis against infection after an operation on bone. The operations involved the insertion of a Moore prosthesis, an Ender and Küntscher nail, a bone-plate, or another device for internal fixation. Patients who had an open fracture or a total joint replacement were not included in the study. The three groups were similar with regard to mean age, sex ratio, duration of preoperative hospitalization, underlying risk factors, and type of operation. The rates of wound infection were not significantly different in the three groups (p = 0.8) or when the rates were stratified according to the type of operation (p greater than 0.3). Staphylococcus aureus and gram-negative bacilli were the most common infecting microorganisms. The rate of mortality related to infection was similar in all three groups (p = 0.2). No adverse side-effects of drugs were encountered. A single preoperative dose of cefonicid, three doses of cefamandole, and five doses of cefamandole were equally effective prophylaxis against infection of the wound in these patients.

[Short term post-surgical prophylaxis in gynecology. Use of cefonicid]. / Profilassi post-chirurgica "short-term" in ginecologia. Uso del cefonicid.

In this study the Authors have evaluated the use of cefonicid in "short-term" post-surgical prophylaxis in gynecology. No effects, nor alteration to hematochemical parameters related to the administration of this medicine have been observed and the analysis of data shows that the use of cefonicid contributes to reducing the incidence of post-surgical infections in hospital in a cure group compared to a control group.

Penetration of cefonicid into serum, salpinges, cervix and vaginal tissue.

Cefonicid is a new cephalosporin that, given in adequate concentrations is able to kill some pathogens such as Gram-positive cocci and many Enterobacteriaceae. In this study we have evaluated 40 patients receiving 1 g of cefonicid i.m. at various times before abdominal or vaginal hysterectomy. The results of the present study indicate that a single dose of 1 g of cefonicid given intramuscularly is useful as prophylaxis and treatment of gynecological infections.

Therapeutic efficacy and renal effects of cefonicid in the treatment of difficult urinary tract infections.

UNLABELLED: EFFICACY, renal effects and nephrotoxicity of the cephalosporin cefonicid (CEF) were evaluated in 11 adult patients with urinary tract infection and varying renal function (creatinine cl 19-161 ml/min, mean 75). CEF was administered i.m. for 7 days at a daily dose adjusted to renal function of the patients. EFFICACY: At the 4th day and at the end of the treatment urine cultures were negative in all cases; a recurrence of the infection was observed in 4 patients 10 days after completion of therapy. Renal effects and nephrotoxicity: CEF neither modified plasma creatinine, urea, uric acid and their renal clearances nor glomerular filtration rate. Only the urinary enzyme activity of alanine aminopeptidase increased slightly at the end of the therapy. It returned to basal values in the post-treatment period. Urinary enzyme activities of gamma-glutamyltransferase, alkaline phosphatase, N-acetyl-beta-D-glucosaminidase and lysozyme were unmodified during and after treatment with CEF. These results indicate that CEF is an effective antimicrobial agent which does not influence renal function, nor cause nephrotoxic effects.

Cefmetazole and cefonicid. Comparative efficacy and safety in preventing postoperative infections after vaginal and abdominal hysterectomy.

A single 1-g dose of cefmetazole was compared with a single 1-g dose of cefonicid for prophylaxis in vaginal and abdominal hysterectomy to determine their efficacy and safety. The antibiotics were administered intramuscularly 15-90 minutes before the incision was made. Cefmetazole and cefonicid had similar activity against most of the aerobic organisms recovered, but cefmetazole was significantly more active against anaerobic gram-negative microorganisms. The patterns of regrowth of vaginal flora were similar in the two treatment groups. Patient demographic characteristics and surgical procedures were similar in both groups. The difference in primary prophylactic failure (e.g., cuff cellulitis) with the two study drugs (1 of 53 [1.9%] with cefmetazole and 2 of 28 [7.1%] with cefonicid) did not reach statistical significance, and the results were similar for the two routes of hysterectomy. Cefmetazole, at a dose of 1 g intramuscularly preoperatively, is a safe and effective agent for prophylaxis during hysterectomy.